On July 25, new legislation redefining Americans’ access to healthcare went into effect in Montana. Already known as a frontier, this state has been a pioneer of what are known as “Right to Try” laws.
With the pace of new medical treatments accelerating far beyond the speed of approval from U.S. regulatory agencies, recent years have seen many Americans leave the country for cutting edge (yet often unregulated) treatments. To address this disparity and the rising numbers of sick Americans legally prevented from accessing potential options at home, many states have passed enhanced healthcare access laws of their own. Perhaps like with marijuana policy, these states have decided that the importance of liberalizing restrictions outweighs the risks of clashing with federal law.
Far from fighting the states on this matter, though, the federal government has been following their lead. Before enacting their own 2018 Federal Right to Try Act, 41 states had already passed bills allowing people with terminal illnesses to receive treatments not yet fully approved by the Food and Drug Administration (FDA)—the U.S. agency that approves which foods and treatments can be sold to Americans. If a treatment passes FDA Phase 1, proving itself to be safe, such patients may consent to and access these therapies.
“The federal government does want states to act as the laboratories for policy,” said Ken Bogner, Montana State Senator, District 19. “So that they can take the best of the best around the country and apply it at the federal level.”
Having observed how this first wave of Right to Try legislation unfolded, Senator Bogner felt confident introducing a bill that went even further. In 2023, five years into his legislative tenure, Bogner’s successful Senate Bill 422 expanded Right to Try to non-terminal patients. After all, while restricting terminal individuals’ access to care was the most egregious failure, many other examples of regulatory misalignment have been evident through Americans flying away to seek treatments for chronic pain, mental health, corrective surgeries, general longevity, and more.
From his rural, southeast Montana district, Sen. Bogner’s original motivation for his bill was a non-terminal one: to help his aging constituents maintain their way of life.
“I ran on a platform of rural economic development. And [it] became clear that it wasn’t necessarily the [economic] policies,” he recalled. “The older generation was struggling to help the next generation because either they’ve gotten older and just didn’t have the energy… Or they were spending their disposable income on healthcare costs.”
Bogner wondered what a state might do to increase access to treatments for age-related health problems.
“So, I came up with an idea,” Bogner said. “Why don’t we expand medical Right to Try? Why do you have to be terminally ill to get treatments that you want or need?”
Senate Bill 422 removed this requirement—as have several other states since then in what is now known, collectively, as “Right to Try 2.0.” Two years later in 2025, The Treasure State passed Bogner’s Senate Bill 535, creating the framework for clinics to administer these treatments. Then, in July, these framework rules took effect, enabling facilities to submit the licensing application to open physical centers.
These treatment centers apply to the state. The treatment developers—biotech and pharmaceutical companies—apply to a newly-created review board.
“There’s three different priorities here,” said Steve Martin, U.S. Lead for the company and biotech innovation hub, Infinita, who assisted Sen. Bogner in drafting the legislation. “There’s the review boards, the biotechs, and the clinics, all of which are completely separate.”
Steve continued, explaining this three-legged stool.
“A biotech comes to a review board to get approval for its treatment protocol,” he shared. “Once it’s approved, they then take that treatment protocol to a clinic and they say, ‘Hey, we want to treat patients. Can you do this?’ And if the clinic says ‘Yes,’ patients can go get treatment at that clinic.”
Now living in Montana, Steve was drawn to this cause following his own recent healthcare access struggle.
“I injured my spine,” he recalled. “And I was trying to access some stem cell treatments that were in the clinical pipeline.”
Yet despite the 2018 Federal Right to Try Act and the liberalized policy of the state in which he sought the treatment, Steve said he discovered that “all these laws are pretty useless. I couldn’t get a hold of anything.”
Already working in the biotech industry at the time, Steve began researching right to try laws, which led him to Infinita and the role he has today.
Infinita promotes biotech development by building an ecosystem of biotech companies and clinics for early patient access options. Initially focused within the Próspera economic development zone on Roatan Island, Honduras, Infinita is now shifting focus to the U.S.
In addition to supporting SB535, Infinita has formed the first review board for this new healthcare system. Officially labelled Experimental Treatment Review Boards (ETRB), they serve as safety and ethical gatekeepers for experimental therapies entering the state—evaluating the safety data and approving treatment protocols for use in Montana.
Steve said initial correspondence with interested companies has mostly been with startups focused on life-saving treatments.
“The most popular indications are oncology (cancer) and neurodegenerative,” he said.
Other potential treatments include those addressing disabilities such as hearing loss, tissue regeneration, and other non-terminal impairments comprising a newly-coined area of care: healthspan.
“It’s not just about living longer. It’s about living a longer, healthier life,” said Marci Torres, defining this term. Marci is Founder and CEO of Wildcreek Life Sciences, the first company to announce its application to become an Experimental Treatment Clinic (ETC).
Echoing the motivation for Sen. Bogner’s initial bill, Marci represents the third leg of this legislative stool alongside the biotech companies and review boards. With a 30-year background spanning public health, military health systems, higher education, and healthcare operations—and her state now the center of this medical movement—Marci is taking this opportunity, she said, to “be a part of something that could have such a massive impact on our health care system as a whole.”
In the run-up to opening their doors in Bozeman early next year, Marci has also been hearing from several biotech companies, further foreshadowing the kinds of new services and treatments they’ll begin administering in 2027. These include potential breakthroughs in cell and gene treatments for various diseases; healthspan therapies (treating chronic pain, hearing/vision, and vitality infusions), and longevity treatments for those wanting to delay the onset of aging in general.
One disadvantage of being out in front of this issue: getting ahead of how insurance companies cover treatment expenses.
“It’s all out of pocket,” Marci stated.
The spirit of providing healthcare access, though, has inspired ways an all-cash clinic can open its doors to many. A percentage of Wildcreek’s profits “will go toward creating access for people who can’t afford [care],” Marci explained, adding they’ll also partner with disease-specific foundations and groups such as those serving veterans, so patients can apply for funding. Helping enforce this, SB 535 requires licensed clinics to allocate at least 2% of their net annual profits toward patient access.
Yet insurance coverage isn’t the only wrinkle when breaking ground in healthcare. Getting out ahead of the whole healthcare industry raises significant difficulties and scrutiny.
Bioethicists and patient advocacy groups, for example, have long asserted that administering experimental treatments disrupts the controlled settings necessary for clinical testing of new drugs. Also, in Montana, some in the public have interpreted “experimental” to mean risky or fringe, including “snake oil” treatments being sold to those desperate for a cure. Finally, pro-life groups in the state raised concerns about treatments using stem cells from aborted pregnancies.
Marci directly addressed this matter of stem cells.
“We’re not sourcing anything from embryonic cells,” she explained. Then, during a subsequent fact-check of this story, Marci solidified her stance, declaring, “No abortion-derived tissue. No embryonic stem cells. No embryo is created or destroyed at any point in our pipeline.”
Regarding the worry about experimental treatments, Sen. Bogner pointed out the bill’s guardrails.
“…these therapies have to complete Phase 1 safety trials,” he emphasized. “They have to go through an Experimental Treatment Review Board. It’s not a free-for-all.”
Finally, a response to the clinical testing objection took place on the industry’s turf, so to speak, when Infinita founder and CEO, Niklas Anzinger, published his June 9 article on PharmExec.com. In it, he pointed out how clinical trials today struggle to find test subjects because they have become unnecessarily exclusionary.
“In Alzheimer’s, over 90% of real-world patients are excluded from the leading trials,” he wrote. As a result, Niklas added, these studies (much like the patients themselves) are going overseas, as the “U.S. share of new trials has fallen from 49% in 2015 to 33% in 2025.”
Niklas countered, in fact, that Montana’s new healthcare infrastructure helps trials by generating real-world human outcome data and creating a parallel revenue stream, addressing another large reason trials fail—expense.
Lastly, there is the ethical matter: With so many trial candidates denied, Montana’s new clinics offer a potential alternative for suffering people seeking recovery options.
If only the drug-makers would get on board.
Unfortunately, perhaps ironically, the federal government’s passivity—while allowing states to expand these rules—is also interfering with activity in this space by not explicitly permitting it. The Montana legislation’s distance from federal policy scares away the industry’s biggest players.
“Big Pharma, for the most part, isn’t going to participate in this because they have too much to lose,” Steve summarized. “If an adverse event happens in a clinic under a state law—even if the patient was late-stage or complex—it creates a headline that can tank their stock or pause their main FDA approval track.”
Crossing the FDA is also a great concern for foreign companies, as seen in the ongoing case of toddler Brody DeVault.
Brody is an American boy with a rare genetic condition called creatine transporter deficiency. The lack of creatine in the brain leads to complications such as developmental delays, motor impairments, and severe speech limitations.
There is no known cure.
So, Brody’s father, Kris, was excited when learning a French biotech company, Ceres Brain Therapeutics, had developed a potential treatment and is even now planning a Phase II trial for people with Brody’s condition. But the trial takes place in France, and fully approved access to this drug for U.S. patients is still years away.
A July 31, 2026, story from MIT Technology Review titled, Montana’s new “right to try” law can’t come soon enough for some, introduced this new legislation as the potential answer to these federal regulatory burdens. And yet, despite Ceres’s CEO “finding Montana’s legislation and clinical infrastructure to be ‘suitable for our drug,’” he hesitates to provide the medication through an ETC for fear of “getting on the wrong side of the FDA.”
Consequently, both Kris DeVault and Steve Martin have approached the FDA requesting legal assurances for biotech companies, ultimately enabling access to these possible cures.
“State laws create the legal pathway, but federal ambiguity keeps the biggest players in the stands,” Steve argued.
Yet, remaining attached to their three-phase clinical testing model, according to Steve, the agencies in D.C. have remained largely unmoved.
This presents a Catch-22: Federal regulators remain in a wait-and-see posture toward state-level Right to Try expansions, but that very ambiguity keeps companies with “the most promising treatments” from participating, Steve assessed.
So, for now, hope for new cures via this expanded healthcare access may best lie in the very phenomenon exercised by Montana’s SB535: Decentralization in medicine. The move away from one giant regulatory framework now rigid with bureaucratic sclerosis is being accompanied by moving away from relying on just a few giant pharmaceutical companies.
Today, Kris and Brody may be yet another pair of Americans flying away for better treatment options as they consider a trip to Próspera in Honduras. The founding home of Infinita is also a nascent hub for experimental medical treatments. Back in the U.S., though, Marci sees the future of healthcare going through Montana, observing, “SB535 is the completion of what Federal Right to Try promised.”
The feds won’t have to “wait-and-see” for long. As happened with “Right to Try 1.0,” states are moving swiftly ahead, with New Hampshire, Florida, Nevada, and others drafting and passing their own versions of such healthcare expansions.
And in addition to their governments, many states’ residents have been active.
“I started getting calls and emails from people all over the country,” Senator Bogner recalled when looking back on this legislative journey. “I think we had over a hundred inquiries—patients looking for hope, biotechs looking for a place to actually run these treatments, and clinics wanting to know what the process is to get licensed.”
As tech evolves, so do social institutions. Some governments tighten their rules; others loosen theirs. And as medical technologies improve, and costs to innovate come down, breakthroughs will emerge from all new places. Rather than from a biotech R&D lab in New England or Minnesota and passing through a multi-year, multi-phase gauntlet of FDA approval, a brand-new treatment of tomorrow might be developed on a Honduran island and administered at a clinic in Bozeman.
— Brandon Ferdig
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NOTE: This is the second of two stories written in partnership with Infinita.
I haven’t spent much time educating myself in this space. Just a wonderful article that really opened up my eyes to how things were, are, and could be! Thanks Brandon!